Sample Risk-based Clinical Data Monitoring Plan (CDMoP)

I was very fortunate to present at EMA last week on results of a Phase 3 study where risk-based monitoring was performed in a clinical trial that also used direct data entry (DDE) at the time of the clinic visit. As a result of DDE, there was minimal source document verification (SDV), and when we did SDV, around only 1% or forms, not variables, were changed. We are sharing a redacted CDMoP from that study. For peer-reviewed publications, please visit our website at www.targethealth.com. A very detailed paper will be published shortly in Applied Clinical Trials. Look forward to your comments. Jules T. Mitchel, Target Health, NYC, USA